Kornimate/medical-research-clean huggingface dataset:
effectiveness of proprioceptive training on plantar pressure, balance, posture and gait in individuals with diabetes mellitus type 2

Conditions: Diabetes Mellitus, Type 2

Summary: introduction: diabetes mellitus (dm) can be considered as one of the most important chronic diseases in the public health system, presenting a high cost for health services. along with the increase in diagnosed cases of dm, there is a simultaneous increase in dm-related manifestations, such as peripheral diabetic neuropathy, diabetic foot ulcers and amputations. decreased plantar sensitivity caused by microvascular complications, reduced sensation of vibration and loss of pressure sensitivity may be associated with recurrent falls due to reduced proprioceptive feedback. although much is known about the beneficial results of physical exercise on glucose metabolism and insulin action, there are still few studies that evaluate the effects of different types of physical exercise, especially proprioceptive training, on plantar pressure, balance and posture of individuals. objective: the present study aims to evaluate the efficacy of proprioceptive training on plantar pressure, postural balance and posture in adults with type 2 diabetes mellitus. methods: this study is a randomized, double blind, controlled clinical trial (evaluator and statistician) with individuals of both sexes, with type 2 diabetes mellitus diagnosed for at least 3 years, over 45 years of age, that can walk without assistance or supervision of others. two groups will be formed, the control group (cg) and the trained group (tg), and the ideal "n" will be calculated in a pilot study.


Eligibility criteria:
inclusion criteria: * individuals with type 2 diabetes mellitus, diagnosed for at least 3 years * both genders * aged 45 years or over * able to wander without assistance or supervision from others * absence of macroangiopathy * no history of neurological, muscular or rheumatic diseases for the etiology of diabetes * agree to participate in the study, signing the free and informed consent term (tcle) pursuant to resolution 466/12 of the national health council exclusion criteria: * presence of uncontrolled hypertension (systolic ≥ 200 mmhg and / or diastolic ≤100 mmhg); * presence of a rheumatic condition that makes it impossible to perform the movements performed in the evaluation and in the therapeutic intervention; * lack of more than 15% to the proprioceptive training program; * individuals who perform some physical activity * dependence on alcohol and illicit drugs

Keywords: proprioception diabetes mellitus, type 2 postural balance gait posture
improving sleep for healthy hearts

Conditions: Insomnia; Coronary Heart Disease

Summary: this is a pilot study randomizing patients with insomnia and coronary heart disease to either general sleep hygiene counseling and web-based cognitive behavioral therapy for insomnia versus general sleep hygiene counseling alone (followed by the cognitive behavioral therapy at a later date).

for this pilot study, the investigators will recruit up to 30 participants with insomnia and coronary heart disease. another 30 patients will be recruited from another institution. patients will be screened with a modified version of the insomnia severity index (isi), a brief self-report instrument validated for identifying insomnia. the investigators will modify the isi to include exclusionary criteria. the investigators will randomize participants to 6 weeks of access to web based cognitive behavioral therapy for insomnia (wcbt-i) using an internet based cbt-i program plus education provided through access to the harvard sleep education web site (which provides general sleep education information only) compared to 6 weeks of access to the harvard sleep education web site, followed by access to the web-cbt program (a wait list control group). the investigators will test the hypothesis that use of wcbt-i improves sleep quality and sleep duration as measured by sleep diaries and the isi. a secondary goal of the study is to assess the recruitment yields, retention and adherence rates.

Eligibility criteria:
inclusion criteria: * meet criteria for at least mild insomnia based on the insomnia severity index questionnaire results * have established coronary disease defined by: a) prior myocardial infarction or a coronary artery revascularization procedure; b) angiographically documented stenosis (\>70%) of a major coronary artery; or c) prior ischemic stroke without major functional impairment. * minimum age of 18 years old. exclusion criteria: * no daily access to a computer with an internet connection * visual impairment preventing use of a computer * inability to read english * severe uncontrolled medical or psychiatric problems * heart failure with reduced ejection fraction \<35% * high depressive symptoms (phq \> 15) * drowsy driving * \>3 days per week use of hypnotic medications * known untreated sleep disordered breathing, narcolepsy, or restless leg syndrome * shift-workers * prior exposure to cbt-i treatment * dialysis patient

Keywords: cognitive behavioral therapy for insomnia randomized controlled trial
a mouth education program for dry mouth

Conditions: Xerostomia; End of Life; Frailty; Dry Mouth

Summary: the goal of this cluster based intervention trial is to evaluate the effect of a nurse-led patient education program on dry mouth in patients with a life-limiting condition or frailty. the mouth educational program (mep) is a nurse-led patient education program, in which trained nurses use current clinical, palliative dry mouth guidelines in a structured manner to discuss causes, consequences and interventions with the patients and to create an appropriate treatment plan. this intervention will be compared to a control group receiving care as usual. therefore, the main question it aims to answer is: does a nurse-led patient education program reduce dry mouth complaints in patients with a life-limiting condition or frailty? participants will be asked to answer questionnaires and, when part of the intervention group, partake in the mouth educational program (mep).


Eligibility criteria:
inclusion criteria: * 18 years or older; * life-limiting condition or frailty (definition from kwaliteitskader palliatieve zorg nederland (iknl/palliactief, 2017)), * experience the complaint dry mouth ≥ 5 on an 11 point numerical rating scale (ranging from 0=no dry mouth to 10=worst dry mouth ever); * fulfil the surprise question (sq): 'would i be surprised if my patient dies within the year? (no) exclusion criteria: * life expectancy less than 4 weeks; * previous medical history of radiotherapy to the salivary glands or sjogren's syndrome; * a cognitive inability to understand and participate in an educational program (assessed by a member of the regular care team, either doctor or nurse)

Keywords: palliative care educational program oral health
irreversible electroporation(ire) for unresectable rectal neoplasms

Conditions: Rectal Neoplasms

Summary: the purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (ire) for unresectable rectal neoplasms.

by enrolling patients with unresectable rectal neoplasms adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous ire for unresectable rectal neoplasms.

Eligibility criteria:
inclusion criteria: * rectal neoplasms diagnosed by positive biopsy or non-invasive criteria, * not suitable for surgical resection, * eastern cooperative oncology group (ecog) score of 0-1, * a prothrombin time ratio \> 50%, * platelet count \> 80x10\^9/l, * ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post nanoknife procedure, * able to comprehend and willing to sign the written informed consent form (icf), * have a life expectancy of at least 3 months. exclusion criteria: * cardiac insufficiency, ongoing coronary artery disease or arrhythmia, * any active implanted device (eg pacemaker), * women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception, * have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the nanoknife™ ledc system, * are in the opinion of the investigator unable to comply with the visit schedule and protocol evaluations.

Keywords: irreversible electroporation unresectable rectal neoplasms
nicotine replacement therapy in the intensive care unit

Conditions: Delirium; Psychomotor Agitation; Substance Withdrawal Syndrome; Nicotine Replacement Therapy

Summary: the purpose of this study is to determine whether transdermal nicotine replacement therapy is safe and effective for treating nicotine withdrawal symptoms in the critically ill smoking patient.

cigarette smoking remains the leading cause of preventable disease and premature death worldwide. there are about 1.2 billion smokers in the world, half of whom will die from diseases caused by smoking. smoking causes 5 million deaths per year, and if present trends continue, 10 million smokers per year are projected to die by 2025. furthermore, abstinence from the highly addictive tobacco products can lead to withdrawal symptoms. although these symptoms are non-life threatening in healthy and hospitalized adults they are not well described in the mechanically ventilated active smoking patient. retrospective studies found a higher, lower or equal mortality in critically ill patients receiving nicotine replacement therapy compared to patients receiving no nicotine replacement. because of these conflicting results and the absence of a randomized controlled trial studying the efficacy and safety of transdermal nicotine replacement therapy in the critically ill smoking patient a clinical study will be conducted.

Eligibility criteria:
inclusion criteria: any patient admitted to the intensive care unit must meet all of the following criteria to be eligible for the study: * critically ill active smoking patient * being mechanically ventilated * start of study product application within 48 hours after icu admission * expected to be mechanically ventilated for more than 48 hours after start of application of the study product exclusion criteria: any patient admitted to the intensive care unit meeting one or more of the following criteria is not eligible for the study: * patient younger than 18 years * patient or next of kin denying research authorization * pregnancy * breastfeeding women * history of chronic dementia or psychosis * (acute) neurologic disease on admission, possibly confounding study objectives (tbi, stroke, ich/sah, seizures, meningitis, encephalitis, intracranial tumor) * patient receiving any form of nrt within two weeks before admission * patient not understanding dutch * patient with acute myocardial infarction * patient with severe cardiac arrhythmia * patient with unstable or deteriorating angina pectoris * patient with generalized acute or chronic skin diseases interfering with nrt absorption * patient with severe hearing deficiency * moribund patient * patient with known hypersensibility to nicotine or components of the transdermal therapeutic system * patient with known hypersensibility to patches * patient participating in an other study

Keywords: delirium psychomotor agitation substance withdrawal syndrome nicotine replacement therapy
targeted lung denervation for patients with moderate to severe copd

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: the purpose of this study is to evaluate safety of targeted lung denervation (or tld) in patients suffering from moderate to severe copd. it is hypothesized that tld will have a similar safety profile and improved physiological and functional outcomes to a sham-control.

a prospective, sequential two phase multicenter, randomized double-blind, safety, \& feasibility study. the goal of airflow-1 will be to compare two energy doses and select the optimal energy dose to be utilized in airflow-2. the goal of airflow-2 is to compare the optimal energy dose to a sham control. all subjects will be followed for a minimum of 3 years.

Eligibility criteria:
inclusion criteria: * diagnosis of copd with 30% ≤ fev1 \< 60% and fev1/fvc \<70% (post-bronchodilator); * patient ≥ 40 and ≤ 75 years of age at the time of consent; * the patient has no child bearing potential or a negative pregnancy test (serum or urine), if applicable; * smoking history of at least 10 pack years; * non-smoking for a minimum of 2 months prior to consent and agrees to continue not smoking for the duration of the study; * participated in a pulmonary rehabilitation program or engaged in regular physical activity under professional supervision in the past 12 months; exclusion criteria: * has been less than 6 weeks following the resolution of a copd exacerbation or active lower respiratory infection (eg. pneumonia); * history of recurrent respiratory infections and/or copd exacerbations (more than 2 hospitalizations within 1 year of enrollment); * prior lung or chest procedure (eg. lung transplant, lvrs, blvr, lung implant, metal stent, valves, coils, median sternotomy, bullectomy, segmentectomy, or lobectomy); * documented history of asthma diagnosed with onset \<30 years of age, cystic fibrosis, paradoxical vocal cord motion, churg-strauss syndrome, allergic bronchopulmonary aspergillosis, severe interstitial lung disease or active tuberculosis; * pulmonary nodule requiring follow-up or intervention unless proven benign; * daily use of \>10 mg of prednisone or its equivalent at the time of enrollment;

Keywords: copd targeted lung denervation intervention lung function safety device
endoscopic bipolar radiofrequency probe (endohpb) in the management of unresectable bile duct and pancreatic cancer

Conditions: Cholangiocarcinoma; Pancreatic Cancer

Summary: the purpose of this study is to assess safety and ability of the endoscopic bipolar radiofrequency ablation (rfa) probe (endohpb) to produce an improvement in the management of cancer of the bile duct or the pancreatic duct. by using radiofrequency (rf) energy to heat the tissue in the duct prior to insertion of the stent, the surrounding tissue becomes coagulated and this may delay tumour growth and the time before the stent lumen becomes blocked. thereby, allowing increased periods between the need for intervention and further stent deployment. the study will look to see if the endohpb is able to keep the stent open longer and perhaps decrease the number of invasive procedures for occluded (blocked) stents.

only a small proportion of patients with biliary obstruction caused by cholangiocarcinoma or pancreatic cancer are suitable for surgical resection. as the cancer grows, it blocks the drainage of the bile ducts that carry digestive juices from the gall bladder and pancreas to the small intestine. blocked drainage causes abdominal pain, bloating, and nausea. ercp (endoscopic retrograde cholangiopancreatography) is often prescribed. ercp with stent placement is the standard medical procedure for people with bile duct and pancreatic cancer. the purpose of this study is to assess safety and ability of the endoscopic bipolar radiofrequency ablation (rfa) probe (endohpb) to produce an improvement in the management of cancer of the bile duct or the pancreatic duct. by using radiofrequency (rf) energy to heat the tissue in the duct prior to insertion of the stent, the surrounding tissue becomes coagulated and this may delay tumour growth and the time before the stent lumen becomes blocked. thereby, allowing increased periods between the need for intervention and further stent deployment. the study will look to see if the endohpb is able to keep the stent open longer and perhaps decrease the number of invasive procedures for occluded (blocked) stents. the objectives are: • to assess assess the safety and effectiveness of an endoscopic bipolar radiofrequency catheter (endohpb) in the management of unresectable cholangiocarcinoma and pancreatic cancer

Eligibility criteria:
inclusion criteria: * either gender greater than or equal to 18 years of age. * pancreatic cancer or cholangiocarcinoma unsuitable for surgical resection. criteria of unresectability being based on 1) metastatic disease or 2) locally advanced. * biliary obstruction * blocked self expanding mesh metal stent (sems) * subjects capable of giving informed consent * life expectancy of at least 3 months exclusion criteria: * cardiac pacemaker * patient unstable for endoscopy * inability to give informed consent * uncorrected coagulopathy

Keywords: cholangiocarcinoma pancreatic cancer radiofrequency ablation
autonomic and cytokines profiles of patients with ulcerative proctitis

Conditions: Inflammatory Bowel Diseases

Summary: 1. to prove that patients with ulcerative proctitis and proctosigmoiditis have impaired autonomic functions, i.e. increased sympathetic activity and/or reduced vagal tone. 2. to demonstrate inflammatory cytokine imbalance, i.e., increased pro-inflammatory cytokines. presence of these abnormalities would make patients with ulcerative proctitis and proctosigmoiditis good candidates for future sacral nerve stimulation therapy.


Eligibility criteria:
inclusion criteria: * no any systemic diseases; * no proctitis or proctosigmoiditis; * no history of gastrointestinal surgery; * no symptoms of diarrhea or fecal urgency during the past 2 weeks; * not taking any medications except contraceptives during the past 2 weeks; * age 18-65. exclusion criteria: * none.
guided self-determination in the treatment of chronic pain to promote the life skills of the patient

Conditions: Chronic Pain

Summary: the purpose of this randomized study is to find out whether using the danish-developed nursing intervention guided self-determination (gsd) can improve life skills of the chronic pain patient. the hypothesis is "using guided self-determination in the treatment of chronic pain patients will increase the life skills of the patients and thus their life quality in spite of pain".

twenty percent of the danish population suffer from chronic pain, which leads to the second highest financial expense following psychiatric diseases. in treating chronic pain, the main focus is often on diagnosis and treatment rather than life quality and everyday life. several studies point to the fact that the interaction between the health professional and the patient can be improved by the individual patient being educated in taking responsibility for his/her own illness, and by involving the patient in decision making through training communication. gsd is an educational method, comprising 32 semi-structured reflection sheets inviting the patients in groups of 4 through 8 sessions of 150 minutes' duration to reflect on the patient's own situation and to be active in co-operation with the nurses. a total of 192 patients will be included and randomized in either an intervention or in a control group. the difference between the two groups is measured by means of three questionnaires, sf-36, pam and soc, which are answered before and after the intervention as well as 6 months later. the hypothesis is "using guided self-determination in the treatment of chronic pain patients will increase the life skills of the patients and thus their life quality in spite of pain". an alliance is established between the multidisciplinary pain clinic at herlev hospital and the pain clinic at naestved hospital as well as the regional pain clinic at koege hospital to conduct this intervention and thus make the best possible use of interrelated knowledge within the issue.

Eligibility criteria:
inclusion criteria: * 18 years and older, diagnosed with nonmalignant chronic pain exclusion criteria: * patients who do not read, write and understand the danish language * patients with a known medical abuse * patients needing special psychological and/or psychiatric intervention * patients with health-related problems preventing them from participating in a group

Keywords: chronic pain supportive care psychosocial circumstances autonomy support nursing intervention
race-specific propofol titration to effect for procedural sedation

Conditions: Unconsciousness; Apnea, Postanesthetic; Sedative Overdose; Hypoxemia

Summary: prospectively evaluate newly established guidelines and make clinicians aware of inter-racial difference in propofol sensitivity.

the primary motivation in conducting this study is to conduct the implementation science, i.e., formalize and train, and retrain if needed, anesthesia providers in the standard practice of titrating infusion rate to effect and clinically evaluate the effect of race and ethnicity on propofol monotherapy sedation during gi endoscopy. the ultimate goal is to make it less likely that patients from races known to be sensitive to propofol experience inadvertent overdosing.

Eligibility criteria:
inclusion criteria: * patients undergoing propofol sedation at gainesville (gnv) and jacksonville (jax) gi endoscopy suites * age range 18 - 80 years old * patients whose race can be identified from the electronic patient information chart (epic) exclusion criteria: * patients who identify as multiracial in epic * patients who identify as other in epic * patients who refuse to indicate their race in epic * patients whose race is listed as unknown in epic

Keywords: procedural sedation
a mobile intervention for black individuals who engage in hazardous drinking

Conditions: Alcohol Abuse; Anxiety

Summary: the purpose of this study is to develop and examine a culturally adapted, mobile health application for the android and ios platform. the application uses a personalized feedback intervention (pfi) designed to enhance knowledge regarding adverse anxiety-alcohol interrelations, increase motivation and intention to reduce hazardous drinking, and reduce positive attitudes and intention regarding anxiety-related alcohol use among black hazardous drinkers with clinical anxiety.

investigators will develop a culturally adapted, brief, single-session pfi delivered via a mobile health application for the android and ios platform through an iterative approach using expert input and semi-structured interview sessions. next, black hazardous drinkers with clinical anxiety will assess program navigation and conduct usability testing. finally, black hazardous drinkers with clinical anxiety will be recruited to complete the final prototype of the mobile health application in order to evaluate the feasibility, acceptability, and initial effects. initial screening will be conducted via zoom; baseline and post-treatment data will be collected via zoom and 1-week, 1-month, and 3-months follow-up data will be collected remotely.

Eligibility criteria:
inclusion criteria: * being 21 years of age or older * self-identifying as black or african american * meeting criteria for current hazardous drinking pattern * meeting criteria for clinical anxiety * being able to provide written, informed consent * owning a smartphone. exclusion criteria: * current participation in alcohol or other substance abuse treatment * engaged in psychotherapy for anxiety or depression * concurrent use of medication for anxiety or depression * being pregnant by self-report * residence outside of the united states confirmed via survey geolocation * inability to provide a valid united states-issued driver's license or identification card to verify identity.

Keywords: african american black personalized feedback intervention